Welcome to our dedicated page for Palisade Bio news (Ticker: PALI), a resource for investors and traders seeking the latest updates and insights on Palisade Bio stock.
Palisade Bio, Inc. (Nasdaq: PALI) is a clinical-stage biopharmaceutical company whose news flow centers on the development of its lead oral PDE4 inhibitor prodrug, PALI-2108, and related corporate and regulatory milestones. The company focuses on autoimmune, inflammatory, and fibrotic diseases, with particular emphasis on ulcerative colitis (UC) and fibrostenotic Crohn’s disease (FSCD).
News about Palisade Bio frequently highlights progress in its clinical programs. Recent announcements describe completion of Phase 1a and Phase 1b studies in UC, initiation and patient dosing in a Phase 1b study in FSCD, and plans to use these data to support Phase 2 IND submissions to the U.S. Food and Drug Administration. Company updates also discuss trial design elements such as safety, tolerability, pharmacokinetics, pharmacodynamics, and exploratory tissue-level and molecular analyses in intestinal biopsies and blood samples.
Investors and observers can also expect coverage of intellectual property developments, including composition-of-matter patents granted in Canada and Japan for PALI-2108 and related gut microbiota–activated PDE4 inhibitor prodrugs. Financing and capital markets activity is another recurring theme, with press releases detailing underwritten public offerings of common stock and common stock equivalents, as well as the intended use of proceeds to fund Phase 2 development in ulcerative colitis.
Additional Palisade Bio news items include participation in healthcare investor conferences, appointments of clinical and operational leaders with experience in gastroenterology and immunology, and governance matters such as stockholder meetings and special meeting outcomes. For readers following PALI, this news stream provides insight into the company’s clinical timelines, regulatory plans, patent estate, leadership, and financing decisions related to its gut-targeted PDE4 inhibitor prodrug platform.
Palisade Bio, Inc. (Nasdaq: PALI) has announced that CEO Tom Hallam, Ph.D. will present at the H.C. Wainwright Global Investment Conference from September 13-15, 2021. The presentation will commence on September 13 at 7:00 AM ET and will be available for investors to view online. Dr. Hallam will also engage in one-on-one meetings during the conference. Palisade Bio is focused on developing therapies for gastrointestinal complications, with its lead asset, LB1148, showing promising results in earlier trials.
Palisade Bio, Inc. (PALI) announced a second quarter business update showcasing positive topline results from a Phase 2 study of LB1148, revealing an accelerated return of bowel function post-surgery. The company entered a worldwide in-licensing agreement with the University of California and received FDA Fast Track Designation for LB1148. Financial results showed R&D expenses decreasing to $314,000 while G&A expenses doubled to $2.4 million. Cash reserves stand at $12.7 million with a debt of $1.1 million, supporting ongoing clinical developments.
Palisade Bio, Inc. announces a $5.2 million investment from Yuma Regional Medical Center at a stock price of $3.45 per share to accelerate the development of LB1148. The investment follows promising Phase 2 clinical data, suggesting LB1148 could become the standard care for gastrointestinal recovery post-surgery. With nearly seven million surgeries annually in the U.S. potentially benefiting, LB1148 aims to enhance patient recovery and reduce healthcare costs. The agreement includes warrants for additional shares and a commitment to register them within 60 days.
Palisade Bio (NASDAQ: PALI) and Newsoara have announced positive topline results from a Phase 2 trial for LB1148, demonstrating a statistically significant 1.1-day acceleration in the return of bowel function in patients after elective bowel resection surgery (p=0.0008). The study involved 120 patients and showed a favorable safety profile, with only 10.9% experiencing drug-related adverse events. The company plans to advance LB1148 to pivotal Phase 3 trials, highlighting its potential to improve recovery times and reduce healthcare costs.
Palisade Bio, Inc. (Nasdaq: PALI) announces an exclusive licensing agreement with the Regents of the University of California to enhance its technology for detecting protease activity in clinical samples. This agreement expands Palisade's proprietary whole-blood assay, crucial for identifying protease activity linked to chronic GI diseases. The company is advancing its pipeline, particularly with its lead asset LB1148, a Phase 3-ready protease inhibitor showing promising results in a Phase 2 trial. This license is anticipated to bolster Palisade's drug discovery capabilities and patient selection during clinical development.
Palisade Bio, Inc. (Nasdaq: PALI), a late-stage biopharma company, announced the formation of a Clinical Steering Committee (CSC) led by Dr. David Berry to guide late-stage development of its investigational drug LB1148. The CSC is expected to enhance pivotal Phase 3 programs in 2022, focusing on preventing post-surgical gastrointestinal complications. Currently in a Phase 2 trial, LB1148 aims to accelerate bowel function return after GI surgery. Preliminary data from a co-development study with Newsoara is expected soon, marking a critical juncture for the company.
Palisade Bio, Inc. (Nasdaq: PALI) has received Fast Track Designation from the U.S. FDA for its investigational drug LB1148, aimed at reducing surgical adhesions after abdominal surgeries. This follows a prior designation for treating GI dysfunction in pediatric cardiovascular surgery patients.
LB1148 is designed to inhibit digestive proteases released during surgery, potentially addressing serious complications such as small bowel obstruction and chronic pain, which affect over 90% of post-abdominal surgery patients.
Palisade Bio has completed a Phase 2 clinical trial for its lead drug candidate LB1148, aimed at accelerating bowel function recovery post gastrointestinal (GI) surgery. The PROFILE study enrolled over 120 patients in China, focusing on the time to return of bowel function as a primary endpoint. Positive outcomes could significantly advance LB1148’s path towards approval. Early Phase 1 results indicated a 1.3-day reduction in hospital stay. The drug aims to address the critical need for new treatments in post-surgery bowel function.
Palisade Bio, Inc. (PALI) announced a key opinion leader (KOL) webinar on May 13, 2021, focusing on LB1148, its lead asset for gastrointestinal surgery complications. Featuring renowned KOLs, the webinar will cover postoperative bowel function recovery and adhesion reduction. LB1148, a serine protease inhibitor, has shown efficacy in a Phase 2 trial, improving bowel function recovery in cardiac surgery patients. A second Phase 2 trial is ongoing in GI surgery, with plans for a Phase 2/3 trial for pediatric surgeries. Positive Phase 2 data is expected by year-end 2021.
Leading BioSciences successfully completed its merger with Seneca Biopharma, establishing Palisade Bio, Inc., which will begin trading on Nasdaq under the ticker PALI on April 28, 2021. The merger is accompanied by a $20 million private placement led by Altium Capital, enhancing financial resources for trial advancements. Palisade Bio's lead asset, LB1148, shows promise in improving post-operative gastrointestinal function and has received Fast Track Designation from the FDA for pediatric applications. This positions Palisade for significant clinical milestones within the next 12 to 18 months.